Turoctocog alfa information

Turoctocog alfa
Clinical data
Trade names	NovoEight, Esperoct
Other names	recombinant antihemophilic factor
AHFS/Drugs.com	Monograph
License data	EU EMA: by INN; US DailyMed: NovoEight; US FDA: NovoEight;
Pregnancy; category	AU: B2; ;
Routes of; administration	Intravenous (IV)
ATC code	B02BD02 (WHO) ;
Legal status
Legal status	AU: Unscheduled; CA: ℞-only / Schedule D; UK: POM (Prescription only); US: ℞-only; EU: Rx-only; In general: ℞ (Prescription only);
Identifiers
CAS Number	1192451-26-5;
DrugBank	DB09109;
ChemSpider	none;
UNII	969NZA3X9T; P89DR4NY54;
KEGG	D10227; D10758;
ChEMBL	ChEMBL2108175;
Chemical and physical data
Formula	C7480H11379N1999O2194S68
Molar mass	166594.19 g·mol−1

Turoctocog alfa (trade name NovoEight) is a recombinant antihemophilic factor VIII used for the treatment of and prophylaxis of bleeding patients with haemophilia A. It is marketed by Novo Nordisk.^[7]^[9]^[13] It was approved in the United States, the European Union, and Japan in 2013.^[14]^[15]^[11]^[9]

^ "Antihemophilic factor Use During Pregnancy". Drugs.com. 20 January 2020. Archived from the original on 16 July 2020. Retrieved 11 March 2020.
^ "Prescription medicines: registration of new chemical entities in Australia, 2014". Therapeutic Goods Administration (TGA). 21 June 2022. Archived from the original on 10 April 2023. Retrieved 10 April 2023.
^ "Turoctocog alfa (rch)" (PDF). Archived (PDF) from the original on 16 May 2022. Retrieved 29 April 2023.
^ "Esperoct (Novo Nordisk Pharmaceuticals Pty Ltd)". Therapeutic Goods Administration (TGA). 23 June 2023. Retrieved 10 September 2023.
^ "Esperoct". Therapeutic Goods Administration (TGA). 19 June 2023. Retrieved 10 September 2023.
^ "Summary Basis of Decision (SBD) for Esperoct". Health Canada. 23 October 2014. Archived from the original on 31 May 2022. Retrieved 29 May 2022.
^ ^a ^b "NovoEight 250 IU powder and solvent for solution for injection - Summary of Product Characteristics (SmPC)". (emc). 23 December 2019. Archived from the original on 17 January 2021. Retrieved 11 March 2020.
^ "Esperoct 1000 IU powder and solvent for solution for injection - Summary of Product Characteristics (SmPC)". (emc). Archived from the original on 15 January 2021. Retrieved 2 October 2020.
^ ^a ^b ^c "NovoEight (- antihemophilic factor, recombinant kit". DailyMed. 30 November 2018. Archived from the original on 24 March 2021. Retrieved 11 March 2020.
^ Cite error: The named reference Esperoct FDA label was invoked but never defined (see the help page).
^ ^a ^b "NovoEight EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 30 October 2020. Retrieved 11 March 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^ Cite error: The named reference Esperoct EPAR was invoked but never defined (see the help page).
^ Spreitzer H (7 January 2014). "Neue Wirkstoffe – NovoEight". Österreichische Apothekerzeitung (in German) (1/2014): 18.
^ "Novo Nordisk annual report 2013" (PDF). Novo Nordisk. Archived (PDF) from the original on 20 November 2017. Retrieved 11 March 2020.
^ "NovoEight". U.S. Food and Drug Administration (FDA). 19 July 2017. Archived from the original on 22 July 2017. Retrieved 11 March 2020.

[Drugs.com_pregnancy-1] "Antihemophilic factor Use During Pregnancy". Drugs.com. 20 January 2020. Archived from the original on 16 July 2020. Retrieved 11 March 2020.

[2] "Prescription medicines: registration of new chemical entities in Australia, 2014". Therapeutic Goods Administration (TGA). 21 June 2022. Archived from the original on 10 April 2023. Retrieved 10 April 2023.

[3] "Turoctocog alfa (rch)" (PDF). Archived (PDF) from the original on 16 May 2022. Retrieved 29 April 2023.

[4] "Esperoct (Novo Nordisk Pharmaceuticals Pty Ltd)". Therapeutic Goods Administration (TGA). 23 June 2023. Retrieved 10 September 2023.

[5] "Esperoct". Therapeutic Goods Administration (TGA). 19 June 2023. Retrieved 10 September 2023.

[6] "Summary Basis of Decision (SBD) for Esperoct". Health Canada. 23 October 2014. Archived from the original on 31 May 2022. Retrieved 29 May 2022.

[NovoEight_SmPC-7] "NovoEight 250 IU powder and solvent for solution for injection - Summary of Product Characteristics (SmPC)". (emc). 23 December 2019. Archived from the original on 17 January 2021. Retrieved 11 March 2020.

[8] "Esperoct 1000 IU powder and solvent for solution for injection - Summary of Product Characteristics (SmPC)". (emc). Archived from the original on 15 January 2021. Retrieved 2 October 2020.

[NovoEight_FDA_label-9] "NovoEight (- antihemophilic factor, recombinant kit". DailyMed. 30 November 2018. Archived from the original on 24 March 2021. Retrieved 11 March 2020.

[Esperoct_FDA_label-10] Cite error: The named reference Esperoct FDA label was invoked but never defined (see the help page).

[NovoEight_EPAR-11] "NovoEight EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 30 October 2020. Retrieved 11 March 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

[Esperoct_EPAR-12] Cite error: The named reference Esperoct EPAR was invoked but never defined (see the help page).

[Spreitzer-13] Spreitzer H (7 January 2014). "Neue Wirkstoffe – NovoEight". Österreichische Apothekerzeitung (in German) (1/2014): 18.

[14] "Novo Nordisk annual report 2013" (PDF). Novo Nordisk. Archived (PDF) from the original on 20 November 2017. Retrieved 11 March 2020.

[15] "NovoEight". U.S. Food and Drug Administration (FDA). 19 July 2017. Archived from the original on 22 July 2017. Retrieved 11 March 2020.